2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-10-13 to 1981-11-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

6 rabbits were exposed with 0.1 ml test item on intact and abraded skin for 24 hours and observed immediately, 48 h and 72 h after removal of dressing. Skin irritation and corrosion was scored according to the method of Draize.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt

EC Number:

288-950-4

EC Name:

2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt

Cas Number:

85940-63-2

Molecular formula:

C22H17N4Na3O13S4

IUPAC Name:

2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

Himalayan

Remarks:

Hoe: HIMK

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding
- Age at study initiation: not specified
- Weight at study initiation: 2,0 to 2,6 kg
- Housing: individual housing
- Diet (e.g. ad libitum): ad libitum, food from ERKA Z-6000 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) .
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 h

Observation period:

24, 48, 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2,5 x 2,5 cm body surface area on the flank
- Type of wrap if used: cellulose pad (Hansamed), covered with a impermeable polyethylene foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48 and 72 h after application

SCORING SYSTEM:
- Method of calculation: Draize (see table 1 in "Any other information on materials and methods incl. tables")

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

intact skin

Irritant / corrosive response data:

No signs of corrosion or irritation on intact skin were observed after exposure with the test item.
For individual results see table 2 in "Any other information on results incl. tables".

Other effects:

On abraded skin very slight erythema and oedema were observed. Here, erythema were fully reversible within 72 h. Oedema were reversible within 24 h, except 1 animal, where oedema was not reversible within 72 h.

Any other information on results incl. tables

Table 2: Individual Erythema and Oedema Scores

	Time after application	24 h						48 h						72 h
	Animal no.	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
abraded skin - score	Erythema	1	0	0	0	1	1	1	0	0	0	1	1	0	0	0	0	1	0
	Oedema	1	0	1	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
intact skin - score	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this dermal irritation study, the test item is considered to be non-irritant to the skin.

Executive summary:

In a primary dermal irritation study, 6 young adult Himalayan albino rabbits were dermally exposed to 0.1 ml test material for 24 hours to approx. 6.25 square centimetres of the body surface. Animals then were observed for 72 h. Both, the intact and abraded skin was examined. Irritation was scored by the method of Draize.

No signs of irritation on intact skin have been recorded at any of the observation points (24, 48 and 72 h).

In this study, the test item is not a dermal irritant to the skin based on CLP criteria.